Regulatory approvals, pending decisions, and appeals as of August 2025, including US Food and Drug Administration approval. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
Lenacapavir Regulatory Approval
Where We Are Now with LEN for PrEP
The chaos in foreign assistance programs (including discontinuation of major PrEP programs), cuts in staffing and new demands on donor commitments will make decisions on the procurement of LEN for PrEP more complex and uncertain.
In December 2024, the Global Fund and PEPFAR announced a plan to reach 2 million people with LEN for PrEP over three years. Exactly how funding to support this unprecedented introduction program will move forward, in the absence of significant US investment, is far from certain. The other stakeholders, including Global Fund, Gilead, CIFF and the Gates Foundation expressed commitments to the deal, but major questions remain.
HIV Prevention Product Overview
The graphic provides an overview of PrEP products currently available and in late-stage clinical trials.
This file is also available to download as a PowerPoint file.
EXPrESSIVE Phase 3 Trials
Seventeen countries are hosting sites for Merck’s trials of a monthly pill for PrEP. Launch is expected in Q3 2025. This graphic shows where these trials are taking place.
This file is also available to download as a PowerPoint file.
Moving a Product to the Real World
The rollout of oral PrEP demonstrates that people don’t take PrEP simply because it’s available—there needs to be a demand for it, and it needs to be accessible, acceptable and used effectively by those who need and want it. These are the lessons the field is applying to the rollout of the dapivirine vaginal ring (DVR), and injectable cabotegravir (CAB) and lenacapavir (LEN) for PrEP. To reach the UNAIDS target of 10 million PrEP users by 2025, initiations of oral PrEP alone will not be enough—and this graphic shows that the field is beginning to apply past lessons to accelerate introduction of injectable PrEP options.
Download this as a PowerPoint file. And for the latest on lenacapavir, visit here.
Years Ahead in HIV Prevention Research: Time to Market
This timeline shows the potential time points when the next-generation of HIV prevention options might find their way into new programs.
This file is also available to download as a PowerPoint file.
Enhancing Community Engagement in HIV Prevention Clinical Trial Design
Insights from AVAC's clinical trial design academy
Presented at IAS 2025, this poster discusses the goals and lessons learned from the Clinical Trial Design Academy.
Impact of US Funding Cuts on Services for Key Populations
Percentage of key population-serving implementing partners that have reported full or partial termination of the provision of KP services due to US funding cuts (as of April 2025).
Impact of Cuts to the Consortia for HIV/AIDS Vaccine Development (CHAVD)
HIV Vaccine Funding
In May 2025, NIH’s National Institute of Allergy and Infectious Diseases (NIAID) announced that funding for the Consortia for HIV/AIDS Vaccine Development (CHAVD) would end after the current grant cycle in June 2026. With only one more year of funding before the grants end, current plans for research, clinical trials and progress toward a vaccine are all at risk.
The annual funding for the consortia—approximately $67M—represents a significant chunk of the NIH’s funding for HIV vaccine development, and also approximately 10% of all funding for HIV vaccine research globally each year.
Excerpted from PxWire.
Potential Demand for LEN for PrEP
The top 16 PrEP markets, based on 2024 oral PrEP initiations and the possible 2026 injectable market, assuming 60% of new PrEP users choose an injectable, as seen in implementation studies.